BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 2261352 · Received September 23, 2011

    Report

    Report Number
    1823260-2011-05061
    Event Type
    Malfunction
    Date Received
    September 23, 2011
    Date of Event
    September 3, 2011
    Report Date
    November 3, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON THE AVIVA SYSTEM WITHIN 10 MINUTES: 67 MG/DL AND 457 MG/DL. CUSTOMER WAS PLAYING AT RECESS AND HER READING DROPPED TO 67 MG/DL. CUSTOMER WAS SENT TO THE NURSE'S OFFICE WHERE SHE WAS GIVEN A SNACK TO EAT AND CONSUMED ON HER OWN. CUSTOMER THEN TESTED AT 457 MG/DL. CUSTOMER THEN TESTED AT 125 MG/DL ABOUT 45 MINUTES LATER. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND STRIPS, AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ® AVIVA TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 303139

    Patients

    Seq Age Sex Outcome Treatment
    1